Cleared Traditional

K801478 - SSC8 SORENSON SUBCLAVIAN CATHETER

K801478 is the FDA 510(k) clearance for SSC8 SORENSON SUBCLAVIAN CATHETER by Sorensen Research. It is a Class 2 Gastroenterology & Urology device (product code FIQ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K801478 · Sorensen Research · Gastroenterology & Urology device
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Aug 1980
Decision
64d
Days
Class 2
Risk

K801478 is an FDA 510(k) clearance for the SSC8 SORENSON SUBCLAVIAN CATHETER. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sorensen Research devices

Submission Details

510(k) Number K801478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date August 27, 1980
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIQ Cannula, A-v Shunt
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.